targeted-release budesonide for treating primary IgA nephropathy

Budesonide, a second-generation synthetic glucocorticoid , is a medication characterized by low systemic absorption (1):

• exhibits potent local anti-inflammatory effects, enabling the reduction of inflammatory mediators and the suppression of inflammatory cell activity
• demonstrates high specificity for target tissues and is released at designated sites, specifically the distal ileum, utilizing TarGeted Release for Inflammatory conditions of the GI Tract (TARGIT™ technology) to safeguard the renal function of adult patients with primary IgA (nephropathy) IgAN who are at risk of rapid progression
• comprehensive review of clinical trials and studies supported the efficacy and safety of TRF-budesonide in reducing proteinuria and stabilizing renal function in IgAN patients
• oral capsules are designed with an enteric coating that protects the medication from the stomach and upper intestine
  • capsules release the drug in the distal ileum, where Peyer’s patches are present in high density
  • by releasing in the distal ileum, the budesonide acts locally on the gut-associated lymphoid tissue (GALT) to reduce the production of galactose-deficient IgA1 (Gd-IgA1), which is the root cause of the immune complexes involved in the pathogenesis of IgAN

NICE state that (2):

• targeted-release budesonide can be used as an option to treat primary immunoglobulin A nephropathy (IgAN) in adults when:
  • they have:
  • a urine protein-to-creatinine ratio (UPCR) of 90 mg/mmol or more or
  • a protein excretion of 1.0 g/day or more, and
  • it is used as an add-on to optimised standard care that includes, unless contraindicated:
    • the highest tolerated licensed dose of renin-angiotensin system inhibitors (RASi) or
    • a dual endothelin angiotensin-receptor antagonist (DEARA)

The NICE committee noted "..Clinical trial evidence shows that targeted-release budesonide plus optimised standard care increases how long people have before their condition gets worse compared with optimised standard care alone..."

Reference:

1. Qi FF, Zeng HQ, Zhang JJ. Targeted-release budesonide: A comprehensive review on its potential in IgA nephropathy. Heliyon. 2025 Feb 15;11(4):e42729.
2. NICE (February 2026). Targeted-release budesonide for treating primary IgA nephropathy